New fees for marketing authorisation applications in force

News 13/10/2010

13/10/2010 – The European Medicines Agency reminds applicants that revised implementing rules on fees payable to the Agency apply as of 7 October 2010.

The revised rules include new, reduced fees for the third and subsequent type-II variations in a grouping or worksharing application, and for additional strengths or potencies of the same pharmaceutical form in an application for an extension of marketing authorisation.

They also include amendments to the fees for grouped variations to plasma and vaccine antigen master files, and to annual fees.

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